The presence of unidentified particles in batches of Gilead Science’s Vistide has led to a recall of the product, which is used to treat symptoms of AIDS.
The voluntary recall only affects Vistide (cidofovir injection) from manufacturing lot number B120217A, which began shipping in October 2012 to the US, Europe and Canada.
Gilead said that “particulate matter was found in some vials during packaging operations”, noting that the consequences of such matter in an intravenous injection like Vistide could be very serious.
“Effects can range from no detectable clinical morbidity to allergic/anaphylactic reaction, tissue necrosis in one or more organs, stroke, myocardial infarction, respiratory failure, and loss of renal or hepatic function; which could result in death,” said Dr Hans Reiser, senior VP, medical affairs at Gilead in the company’s recall letter to healthcare professionals.
Vistide is indicated to treat AIDS patients with the cytomegalovirus (CMV) retinitis, which is an eye condition that involves inflammation of the retina that can lead to blindness.
It is most likely to affect people with weakened immune conditions, meaning people with AIDS are among those most at risk.
The drug is usually given to patients in a hospital setting or doctor’s office, and healthcare professionals are advised stop to dispensing any Vistide from the affected lot immediately and to put these products in quarantine.
Healthcare professionals are also encouraged to get in touch with any patients they may have given the affected Vistide to and notify them of the recall.
Alternative treatment options, such as oral valganciclovir, ganciclovir, and foscarnet, should also be considered, with Gilead stating that it has no available lots of Vistide in the supply chain to replace the affected batch.
Gilead noted that there have been no product complaints received in the past twelve months for Vistide in any of its markets, but given that patient safety could still be compromised the company is carrying out an analysis of its global safety database to identify any signals related to particles in Vistide.